Boron neutron capture therapy for malignant melanoma: first clinical case report in China.

A phase I/II clinical trial for treating malignant melanoma by boron neutron capture therapy (BNCT) was designed to evaluate whether the world's first in-hospital neutron irradiator (IHNI) was qualified for BNCT. In this clinical trial planning to enroll 30 patients, the first case was treated on August 19, 2014. We present the protocol of this clinical trial, the treating procedure, and the clinical outcome of this first case. Only grade 2 acute radiation injury was observed during the first four weeks after BNCT and the injury healed after treatment. No late radiation injury was found during the 24-month follow-up. Based on positron emission tomography-computed tomography (PET/CT) scan, pathological analysis and gross examination, the patient showed a complete response to BNCT, indicating that BNCT is a potent therapy against malignant melanoma and IHNI has the potential to enable the delivery of BNCT in hospitals.

A Review of Planned, Ongoing Clinical Studies and Recent Development of BNCT in Mainland of China.

Boron neutron capture therapy (BNCT) is a promising cancer treatment modality that combines targeted boron agents and neutron irradiation to selectively destroy tumor cells. In mainland China, the clinical implementation of BNCT has made certain progress, primarily driven by the development of compact neutron source devices. The availability, ease of operation, and cost-effectiveness offered by these compact neutron sources make BNCT more accessible to cancer treatment centers. Two compact neutron sources, one being miniature reactor-based (IHNI-1) and the other one being accelerator-based (NeuPex), have entered the clinical research phase and are planned for medical device registration. Moreover, several accelerator-based neutron source devices employing different technical routes are currently under construction, further expanding the options for BNCT implementation. In addition, the development of compact neutron sources serves as an experimental platform for advancing the development of new boron agents. Several research teams are actively involved in the development of boron agents. Various types of third-generation boron agents have been tested and studied in vitro and in vivo. Compared to other radiotherapy therapies, BNCT in mainland China still faces specific challenges due to its limited clinical trial data and its technical support in a wide range of professional fields. To facilitate the widespread adoption of BNCT, it is crucial to establish relevant technical standards for neutron devices, boron agents, and treatment protocols.

Biodistribution studies of boronophenylalanine in different types of skin melanoma.

A study of the 10B-enriched Boronophenylalanine-fructose complex(10BPA-F) infusion procedure in potential BNCT patients, including three skin melanomas of extremities, was performed. 10B concentration in tumor(T), blood(B), skin(S) were measured to determine tumor/blood(T/B) and skin/blood(S/B) ratios. T/B ratio for three melanoma patients was in the range 1.48-3.82(average 2.56 ± 0.69). S/B ratio was in the range 0.81-1.99(average 1.29 ± 0.35). Results showed that T/B ratio of nodular metastasis melanoma was higher than superficial spreading melanoma. 10B concentration in skin was higher than blood, which was helpful to avoid over-dose in normal skin.

PGNAA system preliminary design and measurement of In-Hospital Neutron Irradiator for boron concentration measurement.

A prompt gamma neutron activation analysis (PGNAA) system has been recently developed at the 30-kW research reactor In-Hospital Neutron Irradiator (IHNI) in Beijing. Neutrons from the specially designed thermal neutron beam were used. The thermal flux of this beam is 3.08×10(6) cm(-2) s(-1) at a full reactor power of 30 kW. The PGNAA system consists of an n-type high-purity germanium (HPGe) detector of 40% efficiency, a digital spectrometer, and a shielding part. For both the detector shielding part and the neutron beam shielding part, the inner layer is composed of (6)Li2CO3 powder and the outer layer lead. The boron-10 sensitivity of the PGNAA system is approximately 2.5 cps/ppm. Two calibration curves were produced for the 1-10 ppm and 10-50 ppm samples. The measurement results of the control samples were in accordance with the inductively coupled plasma atomic emission spectroscopy (ICP-AES) results.